Say hello to MassDevice +3, a bite-sized view of the top three medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 3 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry.
3. Medtech makers warn on new EU rules
MASSDEVICE ON CALL—Medical device makers that relocated to Europe to take advantage of its easier path to approval are worried about new European Union rules, the Financial Times reports.
Companies such as Middle Peak Medical, which is developing a mitral valve implant, moved some of their operations to the EU to escape the FDA’s more-stringent approval protocols. But the new EU rules could take a bite out of that advantage, they worry. Read more
2. Stealthy Auris Surgical Robotics raises $34M for eye-surgery device
Stealthy Auris Surgical Robotics, which is led by Intuitive Surgical founder Dr. Frederic Moll, said it raised more than $34 million in an equity round.
Redwood City, Calif.-based Auris is developing a surgical robot for ophthalmological procedures. Although Auris did not reveal the names of the 20 backers who joined the $34.4 million round, it listed several venture capital investors as directors in a regulatory filing. Read more
1. Intuitive Surgical shares jump on FDA clearance for new da Vinci robot
Intuitive Surgical shares opened up 11% this morning, after the medical device company said the FDA cleared the latest version of its da Vinci surgical robot, and quickly surged past the $500 mark..
Intuitive said it plans to have its da Vinci Xi device immediately on the U.S. market now that it’s got 510(k) clearance from the FDA, and “will be seeking regulatory clearances to market the da Vinci Xi System around the world.” Read more
